EU QPPV

On behalf of my client, a consultancy company for the Life Sciences industry we have a new role for a Qualified Person for Pharmacovigilance (QPPV).

We are seeking a highly experienced and driven Qualified Person for Pharmacovigilance (QPPV) to join their expanding pharmacovigilance team. As their company-nominated QPPV, you will play a critical role in ensuring compliance with European and UK regulatory requirements, maintaining oversight of pharmacovigilance systems, and acting as the key contact for regulatory authorities within the EEA and UK.

My client strongly believes that a supportive and healthy work life balance is critical for their team to be happy and successful, and so they offer truly flexible working as standard. This applies to both when and where you work, with autonomy and trust given to everyone in our team from day 1.

Overview of the Role:

·      Serve as EEA QPPV under EU Directive 2001/83/EC and related regulations.

·      Maintain an up-to-date overview of product safety profiles and emerging safety concerns.

·      Oversee the conduct of pharmacovigilance activities and ensure timely and compliant submission of regulatory documents.

·      Support the development, implementation, and maintenance of risk management plans and post-authorisation safety studies.

·      Act as the 24/7 contact point for competent authorities and the EMA.

·      Ensure robust quality systems, training, and audit readiness across all pharmacovigilance functions.

Key Requirements:

Please find the key requirements for this role outlined below. If you are really interested in this role but don’t meet all the desirable requirements, please do still apply as these are only a guide.

·      Extensive knowledge of EU and UK pharmacovigilance regulations and guidelines

·      Experience in participation in audits and Regulatory authority inspections

·      Documented experience in all aspects of PV in order to fulfil the responsibilities of QPPV

·      Strong leadership skills, with the ability to influence cross-functional teams and external stakeholders

·      Contribute and support resolution in corrective and preventative actions relating to drug safety

·      Strong problem-solving and decision-making skills.

Qualifications:

·      Life Sciences degree (mandatory).

• Based and operating within Ireland (mandatory).
• Minimum of 7 years’ experience in the pharmaceutical industry, with strong pharmacovigilance expertise.

Relevant Knowledge:

·      Directive 2001/83/EC

·      Regulations (EC) No. 726/2004 and 520/2012

·      Commission Implementing Regulation on Pharmacovigilance

·      Good Pharmacovigilance Practices (GVP) Guidelines

·      Human Medicines Regulations 2012 as amended

·      Medical Device Regulations 2002 (with Statutory Instruments)

·      Post-Brexit MHRA Guidance for Medicines and Medical Devices

For full details & Job Spec email your CV to [email protected] or call Tina at +353 1 2784701

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

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